The Perioperative Pain Self-Management Program Trial

NCT04979429 | Active Not Recruiting DMC

• 1 other identifier: IIR 20-115
• Study Type: interventional
• Target: 401
• Locations: 1 country
• Sites: 2

Brief Summary

This study will trial the impact of teaching surgical patients a pain self-management approach to compliment medical post-surgical pain management.

Conditions

Postoperative Pain

Keywords

postoperative pain; opioid

Outcome Measures

Primary Outcomes (1)

• Numeric Pain Rating Scale

  Surgical Site Pain The Numeric Rating Scale (NRS) is a 0-10 measure where 0 = no pain.

  6-months post-surgery

Secondary Outcomes (1)

• opioid use

  time to cessation post surgery (weekly phone calls for the first 6 weeks)

Other Outcomes (5)

• Patient Health Questionnaire 8-item version (PHQ-8)

  Change between pre-surgery and 6-months post-surgery

• General Anxiety Disorder Scale: 7-item (GAD-7)

  Change between pre-surgery and 6-months post-surgery

• Pain Disability Index (PDI)

  Change between pre-surgery and 6-months post-surgery

Study Arms (2)

PePS

EXPERIMENTAL

4 sessions of telephone CBT-based pain self-management in addition to standard perioperative care.

Behavioral: Perioperative Pain Self-management (PePS)

Standard Care

NO INTERVENTION

Standard perioperative care.

Interventions

Perioperative Pain Self-management (PePS) BEHAVIORAL

4 sessions of telephone CBT-based pain self-management.

Also known as: PePS

PePS

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• scheduled for total hip, knee, or shoulder joint arthroplasty through the Iowa City, IA, Des Moines, IA, Minneapolis, IA, or Milwaukee WI, VA medical centers

You may not qualify if:

• inability to complete study forms/procedures because of a language/literacy barrier
• active bipolar or psychotic disorder
• history of brain injury
• dementia
• CBT therapy within the past year
• lack of access to a telephone for PePS sessions

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (2)

Iowa City VA Health Care System, Iowa City, IA

Iowa City, Iowa, 52246-2292, United States

Location

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417-2309, United States

Location

Related Publications (1)

• Hadlandsmyth K, Burgess DJ, Leparski RF, Odom AS, Campbell EJ, Obrecht AA, Adamowicz JL, Cho H, Steffensmeier KS, Johnson NL, Richards CC, Vander Weg MW, Lund BC, Yoon P, Mosher HJ. The Perioperative Pain Self-Management (PePS) randomized controlled trial protocol: Preventing chronic post-surgical pain and prolonged opioid use. Contemp Clin Trials. 2022 Jul;118:106810. doi: 10.1016/j.cct.2022.106810. Epub 2022 May 31.

  PMID: 35660486 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Katherine E Hadlandsmyth, PhD MA MS

  Iowa City VA Health Care System, Iowa City, IA

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will be blinded to randomization status.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Participants will be randomized to either receive the pain self-management sessions (PePS) or standard care (SC).

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: July 28, 2021
• Study Start: August 3, 2021
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: August 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)